Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore

NCT06418425 | Recruiting

• 2 other identifiers: 2023/00860EPHF-C/2023/POV/S/4
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial that is designed to study the effectiveness of home-based exercise program and high dietary protein counselling in preventing frailty among elderly in Singapore primary care setting.

Conditions

Frailty

Keywords

frailty; pre-frailty; primary care; exercise; high protein diet; nutrition

Outcome Measures

Primary Outcomes (1)

• Repeated Chair Rise Test

  Measured with repeated chair rise test which is a functional performance frailty metric. As the intervention is more exercise based, the primary outcome will be able to capture the changes brought about by the intervention.

  Baseline, 3 months, 12 months

Secondary Outcomes (6)

• Clinical Frailty Scale (CFS)

  Baseline, 3 months, 12 months

• Short Physical Performance Battery (SPPB)

  Baseline, 3 months, 12 months

• Health-related Quality of life

  Baseline, 3 months, 12 months

• Sarcopenia

  Baseline, 3 months, 12 months

• Physical activity

  Baseline, 3 months, 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants randomly assigned to the intervention group will be taught specific resistance, balance and aerobic exercises by the care co-ordinator and participants will receive a leaflet with pictorial guide on the home-based exercise regime. The participants will be given a monitoring log to record the date and frequency of exercise they do. The participants will be advised to consume adequate protein and they will also receive another leaflet on protein consumption as part of a balanced diet.

Behavioral: counselling on home-based exercise program and dietary protein intake

Usual Care

NO INTERVENTION

Participants in the control group will receive usual care at the polyclinic which does not include counselling on dietary protein intake and home-based exercise program.

Interventions

counselling on home-based exercise program and dietary protein intake BEHAVIORAL

Participants in the intervention group will be on a home-based exercise program and go through counselling on dietary protein intake with the aim of achieving prevention of frailty status. Participants will be required to attend the 3 study visits throughout the study period. Research procedures include physical measurements (eg. Weight, height, waist and hip circumference, calf circumference, hand grip strength, blood pressure, short physical performance battery tests), administration of questionnaires on sociodemographics, physical activity, dietary habits, smoking, alcohol, health conditions, health-related quality of life, clinical frailty status and sarcopenia screening. At three months and twelve months, the intervention group participants will see the care coordinators who will check their compliance to the exercise programme and high protein diet, reinforce the interventions.

Intervention

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years old
• Community dwelling
• On chronic disease follow up with polyclinic
• Ability to communicate in English or Mandarin
• Able to understand the study and give consent

You may not qualify if:

• Individuals with existing dietitian/ physiotherapy intervention (Individuals who are already seeing dietitian for special delivery requirements, or seeing physiotherapist for musculoskeletal exercises for specific condition or injury)
• Institutionalized individuals
• Individuals with significant medical conditions limiting their physical activity or high protein diet, such as severe heart conditions, recent strokes, active malignancy, chronic kidney disease stage 3-5 etc.
• Terminal illness with life expectancy \< 12 months
• severe audiovisual impairment
• Not able to communicate in English or Mandarin
• Pregnant women ( as population involves participants beyond childbearing age, investigators do not expect to include pregnant women in this study)

Sponsors & Collaborators

• National Healthcare Group Polyclinics: lead
• National Healthcare Group, Singapore: collaborator

Study Sites (1)

Ang Mo Kio Polyclinic

Singapore, Singapore, 569666, Singapore

RECRUITING

Related Publications (2)

• Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, Palomera E, Tarradelles M, Papiol M. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017 May 1;46(3):401-407. doi: 10.1093/ageing/afw242.

  PMID: 28064172 BACKGROUND

• Travers J, Romero-Ortuno R, Bailey J, Cooney MT. Delaying and reversing frailty: a systematic review of primary care interventions. Br J Gen Pract. 2019 Jan;69(678):e61-e69. doi: 10.3399/bjgp18X700241. Epub 2018 Dec 3.

  PMID: 30510094 BACKGROUND

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Liew Pui Mun Doctor, MBBS

  National Healthcare Group Polyclinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liew Pui Mun Doctor, MBBS

CONTACT

63553000; pui_mun_liew@nhgp.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research coordinator who assesses the outcomes will be blinded. This clinical research coordinator is different from the one taking the informed consent and performing the randomisation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants meeting the eligibility criteria, will be approached by the care coordinator. If interested in participating, they will be referred to the research team member for recruitment and consent will be taken. Participants will then be randomly assigned to "intervention" or "usual care" parallel arms. Randomisation of participants will be done on 1:1 allocation to intervention or usual care using block randomisation. Allocation will be concealed using opaque envelopes.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: April 18, 2024
• Primary Completion: March 31, 2026
• Study Completion: April 18, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)